Gallbladder model

ABSTRACT

An anatomical model for surgical training is provided. The model includes a first layer simulating a liver and a second layer including a simulated gallbladder. A third layer having an inner surface and an outer surface is provided between the first and second layer. The outer surface of the third layer is adhered to the first layer at location around the simulated gallbladder and the simulated gallbladder is adhered to the inner surface of the third layer. A fourth layer is provided that overlays both the second layer and the simulated gallbladder. A frame is embedded within the first layer and is connectable to a support. The model provides a substantially upright projection of a simulated gallbladder and liver in a retracted orientation ideally suited for practicing laparoscopic cholecystectomy when inserted inside a simulated insufflated cavity of laparoscopic trainer.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to and benefit of U.S. ProvisionalPatent Application Ser. No. 61/836,512 entitled “Gallbladder model”filed on Jun. 18, 2013 which is incorporated herein by reference in itsentirety.

FIELD OF THE INVENTION

This application relates to surgical training tools, and in particular,to simulated tissue structures and models for teaching and practicingsurgical procedures involving a gallbladder.

BACKGROUND OF THE INVENTION

A common treatment for gallstones and other gallbladder conditions is acholecystectomy which is the surgical removal of the gallbladder fromthe liver bed. Laparoscopic cholecystectomy is the most commonlaparoscopic procedure and has replaced open cholecystectomy as thefirst-choice of treatment for gallstones and inflammation of thegallbladder. Laparoscopic cholecystectomy advantageously requiressmaller incisions, resulting in less pain, improved cosmetic results,quicker healing, and fewer complications such as infection andadhesions.

Laparoscopic cholecystectomy requires several small incisions in theabdomen to allow the insertion of trocars or small cylindrical tubesapproximately 5 to 10 millimeters in diameter through which surgicalinstruments and a laparoscope are placed into the abdominal cavity. Thelaparoscope illuminates the surgical field and sends a magnified imagefrom inside the body to a video monitor giving the surgeon a close-upview of the organs and tissues. The surgeon watches the live video feedand performs the operation by manipulating the surgical instrumentsplaced through the trocars.

In a laparoscopic cholecystectomy, a patient is placed in a supineposition on the operating table and anesthetized. A scalpel can be usedto make a small incision at the umbilicus. Using a trocar, the abdominalcavity is entered and enlarged by delivering carbon dioxide gas toinsufflate the cavity to create a working space inside the patient'sabdominal region. The trocar may include an inserted laparoscope forobserving the penetration, insertion, and insufflation of the abdominalspace. Additional trocars are inserted at a location inferior to theribs. Using the laparoscope, the fundus of the gallbladder, which iscovered by the peritoneum, is identified, grasped with a surgicalgrasper extending through one of the trocars, and retracted. A secondsurgical grasper may be used to retract the rest of the gallbladder in alateral direction to expose Calot's triangle. Calot's triangle is thatportion of the gallbladder anatomy that is bound by the cystic duct,cystic artery, the hepatic duct and the border of the liver. The surgeonidentifies the cystic duct and cystic artery. In this area, theunderlying structures are carefully skeletonized from the peritoneumseparating the peritoneum from the both the cystic duct and the cysticartery. A surgical clip applier is introduced through one of the trocarsand clips are applied in two locations to both the cystic duct and thecystic artery. The cystic duct and the cystic artery are then dividedwith surgical scissors between the two locations of clips freeing thegallbladder for removal. The gallbladder is dissected from the bed ofthe liver and removed through one of the trocars. During laparoscopiccholecystectomy, complications may arise due to gallbladder perforationwhich can occur due to excessive traction during retraction or duringdissection of the gallbladder from the liver bed or extraction from theabdomen. The outcome of laparoscopic cholecystectomy is greatlyinfluenced by the training, experience and skill of the surgeonperforming the procedure. In order for residents and surgeons to learnand practice these surgical techniques, a realistic, functional, andanatomically correct model for use in a laparoscopic training device isneeded.

A gallbladder model is not only useful for training residents andsurgeons in laparoscopic cholecystectomy, but also, desirable fortraining residents and surgeons in laparoscopic common bile ductexploration. The common bile duct is a tube that connects the liver,gallbladder and pancreas to the small intestine and delivers fluid toaid in digestion. Common bile duct exploration is a procedure used tosee if a gallbladder stone or some other obstruction is blocking theflow of bile from the gallbladder or liver to the intestine which cancause jaundice. In a laparoscopic common bile duct explorationprocedure, the abdominal cavity is approached as in a cholecystectomydescribed above. The surgeon identifies the common bile duct and a smallhemi-circumferential incision is made in the common bile duct. Acholangiography catheter is inserted into the insufflated abdominalcavity through one of the trocars and into the incision made in thecommon bile duct. Contrast media or radiopaque fluid is introduced intothe cystic and common bile ducts and an X-ray is taken to reveal thelocation of any gallstones in the common bile duct. If there aregallstones, the obstructions will appear as discontinuities in the flowof contrast media. The gallstones are then surgically extracted.

In order to help patient outcomes and recoveries, surgeons need a way topractice laparoscopic cholecystectomies and common bile ductexplorations outside of the operating room. The practice model needs tobe anatomically correct and include all important landmarks normallyseen during surgery in order to give the surgeon or resident the mostrealistic practice possible.

SUMMARY OF THE INVENTION

According to one aspect of the invention, an anatomical model forsurgical training is provided. The model includes a first layer havingan inner surface and an outer surface. The first layer has asubstantially uniform thickness defined between the inner surface andthe outer surface. The first layer has a first perimeter and isconfigured to simulate at least a portion of a first anatomicalstructure. The model includes a second layer having an inner surface andan outer surface. The second layer has a thickness between the innersurface and the outer surface. The second layer defines a secondperimeter and overlays the first layer such that the outer surface ofthe second layer faces the inner surface of the first layer. The modelincludes at least one second simulated anatomical structure which has athird perimeter around the at least one simulated anatomical structure.The at least one simulated anatomical structure is connected to theinner surface of the second layer. The outer surface of the second layeris connected to the inner surface of the first layer at least partiallyaround the location of the at least one second simulated anatomicalstructure.

According to another aspect of the invention, an anatomical model forsurgical training is provided. The model includes an anatomical portionand a support removably connectable to the anatomical portion. Theanatomical portion includes at least a first layer having an innersurface and an outer surface interconnected by a top side and a bottomside and a left side and a right side. The first layer has a thicknessdefined between the inner surface and the outer surface. The first layeris configured to simulate at least a portion of a liver. The top side ofthe first layer has a peak. The model includes a simulated gallbladderpositioned in the location of the peak and facing the inner surface ofthe first layer. The model includes a frame connected to at least thefirst layer. The frame has a first end interconnected to a second end bya central portion. The first end and the second end of the frame areremovably connectable to the support to hold the anatomical portion in asubstantially upright position. The frame does not extend into thelocation of the peak such that the first layer in the location of thepeak is capable of flexing inwardly and outwardly relative to the frame.

According to another aspect of the invention, an anatomical model forsurgical training is provided. The model includes an anatomical portionhaving a first layer. The first layer includes an inner surface and anouter surface interconnected by a top side and a bottom side and a leftside and a right side. The first layer has a thickness defined betweenthe inner surface and the outer surface. The first layer is configuredto simulate at least one anatomical structure. The anatomical portionincludes a second layer that includes at least one anatomical structureoverlaying the first layer. The anatomical portion also includes a framehaving a first end interconnected to a second end by a central portion.At least part of the frame is embedded within the first layer with thefirst end and the second end of the frame extending out from the firstlayer. The model includes a support to which the first end and thesecond end of the frame are removably connectable to the support to holdthe anatomical portion in a substantially upright position with respectto a supporting surface.

According to another aspect of the invention, a surgical simulationsystem is provided. The system includes an anatomical model. The modelincludes an anatomical portion. The anatomical portion includes a firstlayer having an inner surface and an outer surface interconnected by atop side and a bottom side and a left side and a right side. The firstlayer has a substantially uniform thickness defined between the innersurface and the outer surface. The first layer is configured to simulateat least one anatomical structure and defines a substantially planarconfiguration. The model includes a second layer having a plurality ofanatomical structures connected to and overlaying the inner surface ofthe first layer. A support is connectable to the anatomical portion andconfigured to hold the anatomical portion in a substantiallyperpendicular orientation with respect to a supporting surface. Thesystem further includes a surgical training device. The surgicaltraining device includes a base and a top cover connected to and spacedapart from the base to define a simulated insufflated internal cavitybetween the top cover and the base. The internal cavity is at leastpartially obstructed from direct observation by a user. The top coverincludes an aperture or penetrable simulated tissue region. The topcover of the surgical training device is angled to form an acute anglewith respect to a horizontal plane as measured from inside the cavity.The anatomical model is positioned inside the internal cavity a distanceopposite the acute angle such that the inner surface of the first layerfaces the acute angle and the aperture or penetrable simulated tissueregion.

According to another aspect of the invention, an anatomical model forsurgical training is provided. The model includes an anatomical portion.The anatomical portion includes a first layer having an inner surfaceand an outer surface interconnected by a top side, a bottom side, a leftside and a right side. The inner surface is substantially planar andflat and the first layer defines a thickness between the inner surfaceand the outer surface. The first layer is configured to simulate atleast a portion of a liver. The top side of the first layer has a peak.The anatomical portion includes a second layer having an inner surfaceand an outer surface interconnected by a top side, a bottom side, a leftside and a right side. The second layer overlays the first layer suchthat the outer surface of the second layer faces the inner surface ofthe first layer. The outer surface of the second layer is connected tothe inner surface of the first layer along at least part of a firstperimeter. The second layer defines a thickness between the innersurface and the outer surface and the thickness of the second layer issmaller than the thickness of the first layer. The anatomical portionincludes a third layer having at least one simulated anatomicalstructure. The at least one simulated anatomical structure is connectedto the inner surface of the second layer. The anatomical portion furtherincludes a fourth layer having an inner surface and an outer surfaceinterconnected by a top side, a bottom side, a left side and a rightside. The fourth layer overlays the second layer and the third layersuch that the outer surface of the fourth layer faces the inner surfaceof the second layer and the at least one simulated anatomical structure.The outer surface of the fourth layer is connected to the inner surfaceof the second layer along at least part of a second perimeter. Thefourth layer defines a thickness between the inner surface and the outersurface and the thickness of the fourth layer is smaller than thethickness of the first layer. The anatomical portion further includes aframe at least partially embedded inside the first layer. The modelincludes a support connectable to the frame to hold the anatomicalportion in a substantially upright position.

According to another aspect of the invention, a gallbladder model isprovided. The model allows users to practice open and laparoscopiccholecystectomies and common bile duct explorations. The gallbladdermodel includes an anatomical portion connected to a support. Theanatomical portion includes a liver layer, a fascia layer, a gallbladderlayer, a peritoneum layer, and a frame connected together and held in anupright orientation by the support.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top perspective view of an anatomical model according to thepresent invention.

FIG. 2 is an exploded, top perspective view of an anatomical modelaccording to the present invention.

FIG. 3 is a side view of a liver layer of an anatomical portion of theanatomical model according to the present invention.

FIG. 4 is a partial side view of a prong of a frame of an anatomicalportion of the anatomical model according to the present invention.

FIG. 5 is a side, cross-sectional view of a support for an anatomicalportion of an anatomical model according to the present invention.

FIG. 6 is a top perspective view of a laparoscopic trainer for use withan anatomical model according to the present invention.

FIG. 7 is a top perspective view of a frame and support of an anatomicalmodel according to the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Turning now to FIG. 1, there is shown a gallbladder model 10 accordingto the present invention. The gallbladder model 10 includes ananatomical portion 12 removably connected to a support 14. Thesubstantially planar anatomical portion 12 is maintained in an uprightconfiguration by the support 14. In a cholecystectomy, as describedabove in the background section of this application, the fundus of thegallbladder is visible and retracted. In doing so, the remainder of thegallbladder underlying the liver toward the posterior of the patient isuncovered and made visible along with the triangle of Calot in theinsufflated cavity. This retraction involves lifting part of the loweror inferior portion of the right lobe of the liver. With the liver andgallbladder lying substantially in the X-Z plane or frontal plane of thepatient, and the retraction lifting the liver and gallbladdersubstantially into the Y plane or transverse plane of the patient, thegallbladder model 10 of the present invention is a substantial orpartial projection of at least a portion of the retracted liver andgallbladder onto the X-Y plane or transverse plane of a patient. Hence,the gallbladder model 10 represents a substantial planar projection of aretracted liver and gallbladder in a simulated insufflated cavity. Assuch, the gallbladder model 10 configuration advantageously provides asurgical approach to a simulated gallbladder already in a retractedperpendicular orientation when viewed by the user approaching thegallbladder from the location of the umbilicus. Also, the gallbladdermodel 10 configuration permits practice by the user without requiring asecond user to hold portions of the model with graspers in a retractedposition and as such, the model 10 is advantageously designed to be usedby one person at a time. Furthermore, in the model 10, only a portion ofthe liver is simulated, in particular, the right lobe of the liver.Together, with the right lobe, the entirety of the biliary structureincluding the gallbladder is included in the model.

Turning now to FIG. 2, there is shown an exploded view of thegallbladder model 10 comprising an anatomical portion 12 connected to asupport 14. The anatomical portion 12 includes a liver layer 16, afascia layer 18, a gallbladder layer 20, a peritoneum layer 22, and aframe 24 connected together. Each layer will now be described in greaterdetail.

Still referencing FIG. 2, the liver layer or first layer 16 is moldedfrom silicone or thermoplastic elastomer that is dyed with a red colorand configured to simulate a retracted portion of a liver. Inparticular, the liver layer 16 is shaped to represent a portion of theright lobe of a human liver that is retracted to expose the gallbladderand triangle of Calot. Referring to FIG. 3, the liver layer 16 includesa flat planar inner surface 26 and a convex curved outer surface 28. Theinner and outer surfaces 26 interconnect along four sides—a curved topside, a straight bottom side, and a left side and right side thatinterconnect the top and bottom sides. The curved top side includes apeak 30 near or at the left side of the model. The top side curvesdownward from the peak 30 to a lower portion that interconnects with theright side. This peaked shape resembles a substantially planarprojection of a retracted right lobe of a human liver. The peak 30 has alonger length relative to other portions of the liver layer 16. Thethickest portion of the liver layer 16 is approximately 0.5 inches andlocated approximately at the middle. In one variation, the frame 24 ismolded directly into the liver layer 16 such that at least a portion ofthe frame 24 resides inside the liver layer 16 and a portion of theframe 24 resides outside of the liver layer 16 as shown in FIG. 3. Theframe 24 will be described in greater detail below.

Still referencing FIG. 2, the fascia layer or second layer 18 is a thinapproximately 0.01-0.03 inches thick layer made of a thermoplasticelastomer or silicone that is partially translucent, clear or dyed witha slight yellow color. The fascia layer 18 has the same peaked shape asthe liver layer 16 and is sized and configured to overlay the liverlayer 16. The fascia layer 18 has an inner surface and an outer surfacewith the outer surface overlaying a portion of the inner surface 26 ofthe liver layer 16. The fascia layer 18 is attached to the liver layer16 with adhesive that is placed at least along the perimeter such thatthe majority of the middle portion or portions interior from theperimeter of the fascia layer 18 are not attached to the liver layer 16,but instead, are free to remain mobile and separate away from the liverlayer 16. While this fascia layer 18 does not exist in real life, thatis, there is no tissue layer located between the gallbladder and theliver, the gallbladder model 10 of the present invention includes afascia layer 18 which advantageously simulates the dissection andremoval of the gallbladder away from the liver. This advantage will bedescribed in greater detail below.

Still referencing FIG. 2, the gallbladder layer or third layer 20includes at least one body component. In FIG. 2, the at least one bodycomponent is a plurality of anatomical structures. For example, thegallbladder layer 20 includes a gallbladder 32 connected to a cysticduct 34, a common hepatic duct 36 connected to a common bile duct 38, acystic artery 40, and a common hepatic artery 42 connected to andbranching into the right hepatic artery 44 and left hepatic artery 46.All of these anatomical structures are configured to simulate actualhuman anatomy and arranged within the gallbladder layer 20 in ananatomically correct fashion. The gallbladder 32 is a hollow bulbousstructure molded out of silicone or other thermoplastic material dyedwith a light green or yellow color to simulate bile. In anothervariation, the gallbladder 32 is a solid and not hollow structure. Thecystic duct 34, common hepatic duct 36 and common bile duct 38 are alsomade of silicone or thermoplastic material that is dyed with a lightgreen color. The cystic duct 34 is tubular in shape having a tapered endand a diameter of approximately 0.15-0.25 inches. In one variation, thecystic duct 34 has a lumen with a minimum inner diameter of 0.15 inchesand a maximum outer diameter of 0.25 inches making it small enough toclip and large enough to permit insertion of catheter. In yet anothervariation, the cystic duct 34 includes a lumen having an inner surfacethat is lubricated with lubricant. In yet another variation, the cysticduct 34 is larger in outer diameter relative to dimension of a real lifecystic duct 34 to facility training and insertion of a catheter into thelumen. The common hepatic duct 36 and common bile duct 38 are alsotubular in shape having a diameter of approximately 0.15 inches. In onevariation, the cystic duct 34, common hepatic duct 36 and common bileduct 38 are hollow and in another variation they are solid. The cysticartery 40, the common hepatic artery 42, the right hepatic artery 44 andthe left hepatic artery 46 are made from silicone or thermoplasticmaterial that is dyed a red color and molded into a tubular shape havinga diameter of approximately 0.15 inches. In one variation, the cysticartery 40, common hepatic artery 42, the right hepatic artery 44 and theleft hepatic artery 46 are hollow and in another variation they aresolid structures. The gallbladder layer 20 is connected to the fascialayer 18 with selectively-placed adhesive. The gallbladder layer 20 maybe formed from multiple pieces joined together or as a unit with nodisconnects. To form a unitary gallbladder layer 20, the manufacturingprocess consists of a wax form that is dipped in molten plastic andmelted out once the plastic has set.

In one variation, the gallbladder model 10 is configured for practicingbile duct exploration. In such a variation, the biliary structures ofthe gallbladder layer 20 are hollow and filled with fluid that resemblesbile. An exemplary fluid is green-colored dishwashing liquid. The innerdiameter of the hollow biliary structures is approximately 0.09 inchesand the outer diameter is approximately 0.15 inches. The gallbladdermodel 10 that is configured for biliary exploration includes a hollowgallbladder 32 filled with fluid that resembles bile. So that thesimulated bile fluid is not lost, the free ends of the cystic duct 34,common hepatic duct 36, and common bile duct 38 are closed or cappedwith standard tubing caps, solid connectors or barbed connectors thatretain fluid inside the ducts. If not molded as a single unit, biliarystructures made of multiple tubular structures are connected togetherwith connectors. For example, the junction between the common hepaticduct 36 and common bile duct 38 is connected with a connector such as aY-shaped split that permits fluid to flow therebetween. In onevariation, the cystic duct 34 and the common bile duct 38 are connectedvia a connector or molded as a unitary structure such that fluid isallowed to flow between the cystic duct 34 and the common bile duct 38.The employ of connectors is advantageous in that after practicescenarios in which the ducts are cut, such as in a cholecystectomy, thesevered ducts are replaceable with new ducts that are reconnected at thesame locations using the same connectors so that training scenarios canbe repeated. In the gallbladder model 10 that is adapted for biliaryduct exploration, any one or more of the gallbladder 32, bile duct 34,common hepatic duct 36, and common bile duct 38, may include one or moresimulated gallstones (not shown). A simulated gallstone is a smallbead-like structure made of plastic or other material. The simulatedgallstones are placed inside the hollow space of the gallbladder 32and/or inside the lumen of one or more of the cystic duct 34, commonhepatic duct 36, and common bile duct 38. These simulated gallstones areshaped and configured such that they are not visible to the user whenthe model is received but become visible when a syringe and/or catheteris used to inject simulated contrast media fluid such as colored waterinto one or more of the ducts and the continuous flow of contrast mediafluid is visibly interrupted or blocked by the gallstones as thesimulated contrast media fluid fills the biliary structures. In anothervariation, a kit is provided that includes a syringe with which thegallbladder 32 is injected with fluid and/or simulated gallstones. Inanother variation, the gallbladder 32 is not filled with liquid but isfilled with air which may be injectable into the open cavity of thegallbladder 32 with a syringe or other similar device. The cavity of thegallbladder 32 may be pressurized to a pressure greater than ambientsuch that when the gallbladder 32 is inadvertently punctured, as if byan improper surgical technique, the gallbladder 32 noticeably deflatesand as such provides a visual indication to the trainee. In such avariation, the gallbladder 32 has a wall thickness configured to permitobservation of deflation of the gallbladder 32.

Still referencing FIG. 2, the peritoneum layer or fourth layer 22 is athin layer approximately 0.01-0.03 inches thick made of a thermoplasticelastomer or silicone that is clear or partially translucent and/or dyedwith a slightly yellow color. The peritoneum layer 22 is nearlyidentical to the fascia layer 18 and has the same peaked shape as theunderlying fascia layer 18 and liver layer 16. The peritoneum layer 22includes an inner surface and an outer surface overlaying thegallbladder layer 20 and overlaying at least a portion of the innersurface of the second layer 18. In one variation, both the fascia layer18 and the peritoneum layer 22 are each formed by molding liquidsilicone on a layer of foam such as packaging foam or other spongiformstructure and then peeled off the foam after it has set to impart atleast one textured surface to the fascia and peritoneum layers 18, 22.The peritoneum layer 22 is sized and configured to overlay thegallbladder layer 20. The peritoneum layer 22 is attached to the fascialayer 18 with adhesive that is placed in locations that are capable ofdirect contact with the fascia layer 18 without interference from theintervening gallbladder layer 20. Hence, only portions of the peritoneumlayer 22 are adhered to the fascia layer 18 and in one variation, theperitoneum layer 22 is only adhered to the fascia layer 18 and not tothe gallbladder layer 20. In another variation, portions of theperitoneum layer 22 are adhered to portions of the gallbladder layer 20as well as the fascia layer 18. In yet in another variation, portions ofthe peritoneum layer 22 are adhered only to portions of the gallbladderlayer 20. The layers are adhered with adhesive or by the inherenttackiness of the material composing the layers. In essence, theperitoneum layer 22 is selectively adhered to one or more of theunderlying gallbladder layer 20 and fascia layer 18 with adhesive.

Still referencing FIG. 2, the anatomical portion 12 includes a frame 24that is configured to support the entire anatomical portion 12 in asubstantially upright orientation with respect to a table top or othersubstantially flat surface including an organ-receiving tray or othersurface inside a laparoscopic training simulator. The frame 24 includesa left leg 48 and a right leg 50 interconnected by a central portion 52.The central portion 52 is curved and mimics the generally peaked-shapeof the other layers 16, 18, 22. The frame 24 is sized smaller than theliver, fascia and peritoneum layers 16,18, 22. The frame 24 is made ofrigid metal, plastic or other polymer or material that is capable andstrong enough to support the layers of silicone and plastic comprisingthe anatomical portion 12 of the model 10 in an upright orientation. Theleft leg 49 is at or adjacent to the peak and is approximately 3.5-4.0inches long and the shorter right leg 50 is approximately 2.5-3.0 incheslong. The curved central portion 52 is approximately 4.0-4.5 inches longand follows the curvature of the layers 16, 18, 22. The overall heightof the gallbladder model 10 is approximately 5-6 inches and the lengthof the model 10 is approximately 5-6 inches. The left leg 48 defines aleft prong 54 at its free end and the right leg 50 defines a right prong56 at the free end of the right leg 50. The left and right prongs 54, 56extend beyond the anatomical portion 12 for insertion into a support 14.The cross-section of the frame 24 is substantially circular with adiameter of approximately 0.15 inches with the prongs 54, 56 having aslightly larger diameter. Each prong 54, 56 includes a curved,ball-shaped, or spherical-shaped or angled detent 58 as illustrated inFIG. 4 which shows a sectional view of a the left leg 48. The prongs 54,56 have angled distal tips. The frame 24 is connected to the anatomicalportion 12 such that the prongs 54, 56 protrude out from the layers forconnection with the support 14. As described above, in one variation,the frame 24 is molded directly into the liver layer 16 and is clear ortransparent in color or substantially the same color as the liver layer16 in which it is embedded so that it is not readily visible to theuser.

In another variation, the frame 24 does not have a peaked portion and issubstantially U-shaped. As shown in FIG. 7, the central portion 52 ofthe frame 24 is straight and does not follow the peaked-shaped of theother layers 16, 18, 22, This variation provides less support to theother layers 16, 18, 22 in the location of the peak 30 advantageouslypermitting all of these layers to be more flexible and to be more easilypushed distally or proximally relative to areas adjacent to the frame 24to practice the retraction of the liver 16 from the gallbladder 32 whilestill providing support to the overall model 10 in the support 14. Inthis variation, both the right leg 50 and left leg 48 are the samelength approximately 2.5-3.0 inches long instead of the left leg 48 inthe location of the peak 30 being longer. The peak 30 formation in thelayers 16, 18, 22 represents only a portion of the liver, in particular,the right lobe of the liver with all of the anatomical structures of thegallbladder layer 20 being presented in the model 10.

With additional reference to FIG. 5, the support 14 is configured toconnect with the anatomical portion 12 and hold the anatomical portion12 in a substantially upright orientation with respect to a table top orother surface. The support 14 includes a base 60 interconnected with anupright portion 62. The upright portion 62 includes at least two sockets64 that are sized and configured to receive the prongs 54, 56 of theframe 24. The upright portion 62 further includes a spring-biasedplunger 66 in communication with each socket 64. To connect theanatomical portion 12 to the support 14, the prongs 54, 56 are insertedinto the sockets 64 of the support 14. The angled distal tips of theprongs 54, 56 cam against the plungers 66 until they snap into thedetents 58 on each prong 54, 56 to securely lock the anatomical portion12 to the support 14. The anatomical portion 12 may be removed from thesupport 14 by releasing the plungers 66 from each detent 58 or bypulling with force such that the detent 58 cams against the plunger 66moving it out of the way. The anatomical portion 12 can be snapped intothe support 14 or into sockets formed as a removable part of a largeranatomical model, organ tray or laparoscopic trainer. Any type ofconnection fit is within the scope of the present invention forconnecting the anatomical portion 12 to the support 14 including leftand right prongs 54, 56 that are split and splay outwardly as shown inFIG. 7. The prongs 54, 56 are further biased outwardly and ramped toflex past and snap behind a detent to secure the anatomical portion 12to the support 14. To remove the anatomical portion 12, the slit end ofthe prongs 54, 56 are squeezed together by a user from underneath thesupport 14 to permit the prongs 54, 56 to slide past the detent. Theframe 24 and the anatomical portion 12 are separated from the support14.

The gallbladder model 10 can be used to practice open procedures thatinvolve gallbladder anatomy. Also, the gallbladder model 10 isparticularly well suited for practicing laparoscopic gallbladderprocedures. To practice laparoscopic gallbladder procedures, the model10 is placed inside a laparoscopic trainer 68 such as the trainer 68shown in FIG. 6 and described in co-pending U.S. patent application Ser.No. 13/248,449 entitled “Portable laparoscopic trainer” and filed onSep. 29, 2011 by Pravong et al. to Applied Medical Resources Corporationand published as U.S. Patent Application Publication No. 2012/0082970,hereby incorporated by reference in its entirety herein.

Still referencing FIG. 6, the laparoscopic trainer 68 includes a topcover 70 connected to a base 72 by a pair of legs 74 spacing the topcover 70 from the base 72. The laparoscopic trainer 68 is configured tomimic the torso of a patient such as the abdominal region. The top cover70 is representative of the anterior surface of the patient and thespace between the top cover 70 and the base 72 is representative of aninterior of the patient or body cavity where organs reside. Thelaparoscopic trainer 68 is a useful tool for teaching, practicing anddemonstrating various surgical procedures and their related instrumentsin simulation of a patient. Surgical instruments are inserted into thecavity through pre-established apertures 76 in the top cover 48. Thesepre-established apertures 76 may include seals that simulate trocars ormay include simulated tissue region(s) that simulates the patient's skinand abdominal wall portions. Various tools and techniques may be used topenetrate the top cover 70 to perform mock procedures on model organsplaced between the top cover 70 and the base 72 such as the gallbladdermodel 10. When placed inside the cavity of the trainer 68, thegallbladder model 10 is generally obscured from the perspective of theuser who can then practice performing surgical techniqueslaparoscopically by viewing the surgical site indirectly via a videofeed displayed on a video monitor 78. The video display monitor 78 ishinged to the top cover 70 and is shown in an open orientation in FIG.6. The video monitor 78 is connectable to a variety of visual systemsfor delivering an image to the monitor 78. For example, a laparoscopeinserted through one of the pre-established apertures 76 or a webcamlocated in the cavity and used to observe the simulated procedure can beconnected to the video monitor 78 and/or a mobile computing device toprovide an image to the user.

When assembled, the top cover 70 is positioned above the base 72 withthe legs 74 located substantially at the periphery and interconnectedbetween the top cover 70 and base 72. The top cover 70 and base 72 aresubstantially the same shape and size and have substantially the sameperipheral outline. The laparoscopic trainer 68 includes a top cover 48that angulates with respect to the base 50. The legs 52 are configuredto permit the angle of the top cover 70 with respect to the base 72 tobe adjusted. FIG. 6 illustrates the trainer 68 adjusted to an angulationof approximately 30-45 degrees with respect to the base 72. The selectedangulation of the top cover 70 is locked by tightening thumbscrewsprovided on the legs 74. The angulation of the top cover 70 of thetrainer 68 with respect to the base 72 is particularly advantageous withrespect to accommodating the gallbladder model 10 of the presentinvention.

With the top cover 70 angled as shown in FIG. 6, the gallbladder model10 is inserted into the cavity of the trainer 68 and positioned betweenthe top cover 70 and base 72. With the gallbladder model 10 insertedinto the trainer 68, the peritoneum layer 20 faces the front of thetrainer 68. In particular, the inner surface of the gallbladder model 10substantially faces the apertures or tissue simulation region 76. Themodel 10 shares a vertical component with the top cover 70 in the angledorientation. The top cover 70 is angled such that the top cover 70 ispositioned between the user and the gallbladder model 10. The directionof approach by the user is through the apertures, or simulated tissueregion(s) 76 in the top cover 70. Instruments are inserted throughlocations 76 in the top cover 70 to access the gallbladder model 10 forpracticing surgical procedures. Also, a scope is inserted into thetrainer cavity between the top cover 70 and base 72 via one of theapertures 76 to capture video images of the obscured gallbladder model10 and display them to the user via the video monitor 78.

Users practicing laparoscopic cholecystectomy will pass otherinstruments in addition to the scope into the cavity of the laparoscopictrainer 68 to access the gallbladder model 10 inside the trainer 68.Because the model 10 advantageously portrays a retracted gallbladder,the user is not required to use surgical graspers to retract thesimulated liver, nor is it required to have an assistant hold one ormore of the graspers to maintain the retracted position. Instead, thegallbladder model 10 is designed to be used by one person.

In the practice of laparoscopic cholecystectomy, the user will practiceidentifying the triangle of Calot by using an inserted scope to view animage on the monitor 78. After the triangle of Calot is identified, theperitoneum layer 22 is dissected and the cystic duct 34 and cysticartery 40 are approached. Advantageously, because only select portionsof the peritoneum layer 22 are adhered to the underlying layer 18 orlayers 18 and 20, the cystic duct 34 and cystic artery 40 are easilyskeletonized or separated from the peritoneum layer 22. Also, becauseportions of the cystic duct 34 and cystic artery 40 and other elementsof the gallbladder layer 20 are selectively attached to the underlyinglayer, they advantageously maintain their anatomical layout and arestill relatively mobile as they would be in vivo. The mobility of theelements comprising the gallbladder layer 20 relative to the liver layer16 or one or more adjacent fascia or peritoneum layers 18, 22 isadvantageously enhanced not only by the mere existence of such layers18, 22 in the model 10 and the select adhesion of said gallbladder layerelements to one or more of the fascia layer 18 and peritoneum layer 22,but also, by mobility of the underlying fascia layer 18 which itself isselectively adhered to the underlying liver layer 16. Selectiveadherence of one layer to an adjacent layer typically results from theapplication of adhesive in pre-selected areas and the avoidance ofadhesive in strategic areas of the anatomy that demand greater mobilityand/or removal relative to the adjacent layer(s). With regards to thegallbladder 32, the gallbladder 32 is attached to the fascia layer 18that is located above the liver layer 16. This allows the gallbladder 32to be removed from the model 10 without damaging the liver layer 16 oronly slightly damaging the liver layer 16 either of which is a morerealistic outcome to the procedure. The liver is a vascular andsensitive structure and removing the gallbladder without taking too muchof the liver is key to the success of a cholecystectomy and the model 10advantageously allows realization of such outcomes in practice. Whilethe fascia layer 18 does not exist in reality, it aids in the simulationbecause without the fascia layer 18, adhesive cannot be dissected in thesame manner as the real-life connective tissue between the gallbladderand liver. In one variation, the outer surface of the peritoneum layer22 is adhered to the gallbladder layer 20 with adhesive. In the samevariation, the peritoneum layer 22 is also adhered to the inner surfaceof the second layer 18 with adhesive only along at least part of theperimeter. Also, in the same variation, the outer surface of the secondlayer 18 is adhered to the inner surface of the liver layer 16 withadhesive only along at least part of the perimeter. As a result of thisconfiguration, pulling of the peritoneum layer 22 will result in thepulling of the gallbladder layer 20 along with the peritoneum layer 22and a resulting tenting of the combined peritoneum layer 22 andgallbladder layer 20 relative to the second layer 18 and the liver layer16 because the peritoneum layer 22 is attached to the second layer 18only at the perimeter and the second layer 18 is in turn attached to theliver layer 16 only along at least part of the perimeter allowing foradvantageous tenting effect. In a version of this variation, thegallbladder 32 is adhered to the inner surface of the second layer 32.Therefore, pulling of the gallbladder layer 20 and/or the peritoneumlayer 22 and/or gallbladder 32 in a direction substantiallyperpendicular to the layers 16, 18, 20, 22 or away from the liver layer16 will result in a further tenting of the second layer 18 relative tothe liver layer 16 at the location of the gallbladder 32. Because thelayers 18, 22 are stretchy and selectively adhered as described, tentingof the layers 18, 20, 22 will readily occur. Hence, when the peritoneumlayer 22 is pulled in a direction away from the liver layer 16 a firstgap or pocket is formed between the peritoneum layer 22 and the fascialayer 18 by the tenting of the peritoneum layer 22 as a result of thepredetermined and selective adherence. Also, a second gap or pocket isformed between the fascia layer 18 and the liver layer 16 as the fascialayer 18 tents with respect to the liver layer 18 as the fascia layer 18is pulled due to the predetermined and selective adherence of thegallbladder 32 to the second layer 18. Wherein the second gap or pocketis smaller than the first gap or pocket when the peritoneum layer 22 ispulled away from the liver layer 16. Also, the second layer 18 can bemade slightly thicker than the peritoneum layer 22. The peritoneum layer22 and the second layer 18 are thicker than the liver layer 16.

Prior to removal of the gallbladder 32, the user will practiceintroducing a surgical clip applier through one of the apertures 76 ofthe trainer 68 and applying clips in two locations to both the cysticduct 34 and the cystic artery 40. The vasculature and biliary structuresare made of materials that allow the simulated tissue structures tofunction similarly to human anatomy and be pliable, dissectable, andwithstand the application of real clips from a surgical clip appliersuch that when the clips are closed on the structures of the gallbladderlayer 20, they do not sever the structures. The user then insertslaparoscopic scissors through one of the apertures 76 and cuts thecystic duct 34 and the cystic artery 40 between the two locations ofclips. The gallbladder 32 is then dissected from the bed of the liverand removed through one of the trocars inserted in one of the apertures76. The gallbladder 32 is advantageously attached to the fascia layer 18and not directly to the liver layer 16. The presence of a fascia layer18 makes removal of the gallbladder 32 more realistic as described aboveproviding a situs for incision.

The gallbladder model 10 is also useful for training residents andsurgeons in laparoscopic common bile duct exploration. Common bile ductexploration is a procedure used to see if a gallbladder stone or someother obstruction is blocking the flow of bile from the gallbladder orliver to the intestine which can cause jaundice. In the practice of thisprocedure, the gallbladder model 10 is placed in the cavity of thelaparoscopic trainer 68 and the abdominal cavity is approached as in acholecystectomy described above with a scope inserted through one of theapertures 76 in the laparoscopic trainer 68 and the resulting live imagedisplayed on the video monitor 78. The user identifies the common bileduct 38 on the monitor 78. A bladed instrument is introduced into thecavity of the trainer 68 and a small hemicircumferential incision ismade in the common bile duct 38. A cholangiography catheter (not shown)such as the AEROSTAT® manufactured by Applied Medical ResourcesCorporation in California is inserted into the laparoscopic trainer 68cavity through one of the apertures 76 and into the incision made in thecommon bile duct 38. Instead of contrast media or radiopaque fluid,colored water is injected with a syringe into the proximal end of thecatheter and allowed to flow into the cystic and common bile ducts 34,38. The colored water will fill the one or more biliary structuresallowing the simulated gallstones to be seen. Hence, in training forbiliary duct exploration, no fluoroscopy is required to identify thepresence of gallstones in the training procedure employing thegallbladder model 10 of the present invention. If there are gallstones,the obstructions will appear as discontinuities in the flow of coloredwater. The user can then practice locating the simulated gallstones atthe location of fluid flow obstruction or color discontinuity. Once thesimulated gallstones are located the user practices removing thegallstones from the hollow biliary structures.

The present invention further includes a kit for practicing common bileduct exploration. A kit for common bile duct exploration comprises agallbladder model 10 and a syringe of colored water. The kit furthercomprises a catheter and/or a plurality of simulated gallstones whichcan be inserted into the biliary structures of the gallbladder layer 20.The kit may further include replacement sections of any one or moreducts 34, 36, 38 and arteries 40, 42, 44, 46 and/or connectors. Thereplacement ducts have hollow lumens for practicing common bile ductexploration. Other replacement ducts and/or arteries in the kit aresolid diameter structures for replacing ducts and/or arteries that havebeen previously severed in practice of previous procedures.

The gallbladder model 10 of the present invention is particularly suitedfor laparoscopic procedures; however, the invention is not so limitedand the gallbladder model of the present invention can be used in opensurgical procedures equally effectively.

It is understood that various modifications may be made to theembodiments of the gallbladder model 10 disclosed herein. Therefore, theabove description should not be construed as limiting, but merely asexemplifications of preferred embodiments. Those skilled in the art willenvision other modifications within the scope and spirit of the presentdisclosure.

1. An anatomical model for surgical training, comprising: a first layerhaving an inner surface and an outer surface; the first layer having athickness defined between the inner surface and the outer surface; thefirst layer being configured to simulate at least a portion of a firstanatomical structure and having a first perimeter; a second layer havingan inner surface and an outer surface; the second layer defining athickness between the inner surface and the outer surface; the secondlayer having a second perimeter; the second layer overlaying the firstlayer such that the outer surface of the second layer faces the innersurface of the first layer; and at least one second simulated anatomicalstructure; the at least one second simulated anatomical structuredefining a third perimeter around the at least one simulated anatomicalstructure; the at least one simulated anatomical structure beingconnected to the inner surface of the second layer; and wherein theouter surface of the second layer is connected to the inner surface ofthe first layer at least partially around the location of the at leastone second simulated anatomical structure.
 2. The anatomical model ofclaim 1 wherein the second layer is not connected to the first layerinside the third perimeter such that the second layer is permitted totent with respect to the first layer when the second layer is pulledaway from the first layer at a location inside the third perimeter. 3.The anatomical model of claim 1 further including a fourth layer havingan inner surface and an outer surface; the fourth layer defining athickness between the inner surface and the outer surface and having afourth perimeter; the fourth layer overlays the second layer and the atleast one second simulated anatomical structure such that the outersurface of the fourth layer faces the inner surface of the second layerand the at least one second simulated anatomical structure; wherein theouter surface of the fourth layer is connected to the inner surface ofthe second layer.
 4. The anatomical model of claim 3 wherein the outersurface of the second layer is connected to the inner surface of thefirst layer at a location outside the third perimeter as projected ontothe first layer; and wherein the outer surface of the fourth layer isconnected to the inner surface of the second layer at a location outsidethe third perimeter as projected onto the second layer.
 5. Theanatomical model of claim 3 wherein the outer surface of the secondlayer is connected to the inner surface of the first layer at a locationalong at least part of third perimeter as projected onto the firstlayer; and wherein the outer surface of the fourth layer is connected tothe inner surface of the second layer at a location along at least partof the third perimeter or outside the third perimeter as projected ontothe second layer.
 6. The anatomical model of claim 3 wherein thethickness of the second layer and the fourth layer are smaller than thethickness of the first layer.
 7. The anatomical model of claim 3 whereinthe outer surface of the second layer is connected to the inner surfaceof the first layer along at least a part of the first perimeter and theouter surface of the fourth layer is connected to the inner surface ofthe second layer along at least a part of the first perimeter or secondperimeter.
 8. The anatomical model of claim 1 wherein the first layersimulates at least a portion of a liver and the at least one secondsimulated anatomical structure includes a simulated gallbladder.
 9. Theanatomical model of claim 1 wherein the first layer is thicker than thesecond layer.
 10. The anatomical model of claim 1 wherein the innersurface of the first layer is flat.
 11. The anatomical model of claim 1wherein the outer surface of the second layer is connected to the innersurface of the first layer along at least a part of the first perimeter.12. The anatomical model of claim 1 wherein the second layer is notconnected to the first layer at a location inside the third perimeter asprojected onto the overlayed second layer.
 13. The anatomical model ofclaim 1 wherein the third layer is connected to the second layer at orinside the third perimeter.
 14. The anatomical model of claim 1 whereinthe outer surface of the second layer is connected to the inner surfaceof the first layer at a location along at least part of the thirdperimeter or outside the third perimeter as projected onto the firstlayer. 15-42. (canceled)
 43. An anatomical model for surgical training,comprising: an anatomical portion comprising: a first layer having aninner surface and an outer surface interconnected by a top side, abottom side, a left side and a right side; the inner surface beingsubstantially planar; the first layer having a thickness defined betweenthe inner surface and the outer surface; the first layer beingconfigured to simulate at least a portion of a liver; a second layerhaving an inner surface and an outer surface interconnected by a topside, a bottom side, a left side and a right side; the second layeroverlays the first layer such that the outer surface of the second layerfaces the inner surface of the first layer; the outer surface of thesecond layer being connected to the inner surface of the first layeralong at least part of a first perimeter; the second layer defining athickness between the inner surface and the outer surface; wherein thethickness of the second layer is smaller than the thickness of the firstlayer; a third layer including at least one simulated anatomicalstructure; the at least one simulated anatomical structure beingconnected to the inner surface of the second layer; and a fourth layerhaving an inner surface and an outer surface interconnected by a topside, a bottom side, a left side and a right side; the fourth layeroverlaying the second layer and the third layer such that the outersurface of the fourth layer faces the inner surface of the second layerand the at least one simulated anatomical structure; the outer surfaceof the fourth layer being connected to the inner surface of the secondlayer along at least part of a second perimeter; the fourth layerdefining a thickness between the inner surface and the outer surface;wherein the thickness of the fourth layer is smaller than the thicknessof the first layer.
 44. The anatomical model of claim 43 wherein thefirst perimeter is defined around one or more anatomical structure ofthe third layer.
 45. The anatomical model of claim 43 wherein the firstperimeter is defined around the edge of the first layer.
 46. Theanatomical model of claim 43 wherein the second layer is connected tothe first layer with adhesive.
 47. The anatomical model of claim 43wherein the at least one anatomical structure is connected to the innersurface of the second layer with adhesive.
 48. The anatomical model ofclaim 43 further including a peak projecting from the top side of thefirst layer.
 49. The anatomical model of claim 48 wherein the top sideof the second layer includes a peak that substantially matches the shapeof the peak of the first layer such that the peak in the second layerconformingly overlays the peak in the first layer.
 50. The anatomicalmodel of claim 48 wherein the fourth layer includes a peak that conformsto the peak in the first layer and substantially overlays the peak inthe first layer.
 51. The anatomical model of claim 43 further includinga frame at least partially embedded inside the first layer; and asupport connectable to the frame to hold the anatomical portion in asubstantially upright position.
 52. The anatomical model of claim 51wherein the frame includes a left leg and a right leg interconnected bya central portion wherein the frame does not extend into the peak of thefirst layer leaving it capable of flexing inwardly and outwardly. 53.The anatomical model of claim 51 wherein the frame is substantiallyU-shaped and extends along the top side but not inside the peak of thefirst layer; the frame having a right leg and a left leg interconnectedby a central portion; wherein the distal portions of the right leg andleft leg protrude outwardly from the first layer.